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Lenalidomide maintenance following tandem autologous stem cell and non myeloablative allogeneic transplantation for patients with multiple myeloma <= 66 years.


- candidate number5233
- NTR NumberNTR1645
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2009
- Secondary IDsHO76 EudraCT number 2005-003891-39
- Public TitleLenalidomide maintenance following tandem autologous stem cell and non myeloablative allogeneic transplantation for patients with multiple myeloma <= 66 years.
- Scientific TitleLenalidomide maintenance following tandem autologous stem cell and non myeloablative allogeneic transplantation for patients with multiple myeloma <= 66 years.
- ACRONYMHOVON 76 MM
- hypothesis1. Null hypothesis (H0): PFS at 1 year after start lenalidomide maintenance = 59%;
2. Alternative hypothesis (H1): PFS at 1 year after start lenalidomide maintenance = 75%.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease)
- Inclusion criteriaEligibility for registration:
1. Age 18-66 years;
2. Patients with, before start of induction therapy, a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix A), included in or treated according to the HOVON 65/GMMG-HD4, HOVON 95 or treated according to the guidelines of Hovon Myeloma Study Group for patients <= 66 years group in the interval between the HOVON 65 and HOVON 95 study;
3. Patient has received 3 cycles induction therapy, followed by stem cell mobilization and 1 cycle of high dose Melphalan with autologous stem cell reinfusion;
4. WHO performance status 0-2 (see appendix D);
5. HLA-identical family donor;
6. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast;
7. Written informed consent for allo SCT treatment as well as lenalidomide maintenance, preferably signed in the presence of both patient and investigator and signed on the same date.

Eligibility for lenalidomide maintenance:
1. Laboratory test results within these ranges:
A. Absolute neutrophil count >= 1.0 x 10^9/L;
B. Platelet count >= 75 x 10^9/L;
C. Serum creatinine cleareance >= 50 ml/min;
D. Total bilirubin <= 30 ́mol/l;
E. AST (SGOT) and ALT (SGPT) <= 3 x Upper Limit of Normal (ULN);
2. Negative pregnancy test before inclusion if female of child baring potential;
3. Sexually active women of child bearing potential must agree to use 1 adequate contraceptive method while on study drug (and 4 weeks before and after study drug) (for detailed information see section 9.2.2);
4. Men must agree not to father a child and to use a condom if his partner is of childbearing potential.
- Exclusion criteriaEligibility for registration:
1. Creatinin clearance < 50 ml/min;
2. Severe cardiac dysfunction (NYHA classification II-IV, see appendix E);
3. Significant hepatic dysfunction (serum bilirubin >= 30 micromol/l or transaminases >= 2.5 times normal level), unless related to myeloma;
4. Known positive for HIV;
5. Patients with active, uncontrolled infections;
6. Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
7. Progressive disease / relapse from CR / progression from MR or PR after HDM with autologous stem cell reinfusion.

Eligibility for lenalidomide maintenance:
1. Progressive myeloma (see appendix B)(within 3 weeks before start therapy, response must be checked and patients who developed progressive myeloma must be excluded);
2. Acute Graft versus host Disease >= grade 2 (at time of registration);
3. Pregnant or lactating females;
4. Concurrent use since NMA Allo SCT of other anti-cancer agents or treatments or use of any other experimental drug or therapy within 28 days of planned start lenalidomide;
5. Known hypersensitivity to thalidomide;
6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs;
7. Any prior use of lenalidomide;
8. Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 3-dec-2007
- planned closingdate1-apr-2010
- Target number of participants80
- InterventionsAllo SCT + lenalidomide maintenance (max. 24 months).
- Primary outcomePFS (defined as time from start of NMA until progression, relapse or death from any cause, whichever comes first).
- Secondary outcome1. OS (defined as time from start of NMA until death form any cause);
2. Ongoing response defined as the achievement of new VGPR and CR following start of lenalidomide treatment;
3. Adverse events;
4. Acute and chronic GvHD in relation to maintenance treatment with lenalidomide;
5. In vivo immune modulation of lenalidomide.
- Timepoints1. Screening assessments occur from Allo SCT onwards;
2. Screening pregnancy tests for women of child-bearing potential must occur <= 7 days from start Lenalidomide;
3. Schedule the Discontinuation from Study Drug Visit as soon as possible after a subject has been discontinued from the study treatment, regardless of the reason;
4. Follow up contact with the subjects should occur every 3 months.
- Trial web sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- CONTACT for SCIENTIFIC QUERIESDhr. Prof. Dr. H.M. Lokhorst
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase:
II
Study objective:
Efficacy and safety of lenalidomide treatment following non myeloablative Allo-SCT performed after intensive treatment including autologous stem cell transplantation
Patient population:
Patients with multiple myeloma with an HLA-identical sibling donor, participating in or treated according to the HOVON 65/GMMG-HD4 MM trial, and after closure of the Hovon 65 study patients treated according to the guidelines of Hovon Myeloma Study Group for patients <= 66 years group. In addition patients with an HLA-identical sibling donor, will be included participating in the Hovon 95 trial in preparation for patients <= 66 years. NMA allogeneic stem cell transplantation will beapplied between 2 and 6 months after High Dose Melphalan
Study design:
Prospective, multi center, non-randomized
Duration of treatment:
Two years of lenalidomide starting 1-6 months after non myeloablative Allo-SCT.
- Main changes (audit trail)
- RECORD29-jan-2009 - 9-sep-2009


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